Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies

Running, not enrolling · Phase 1

Conditions studied: B-cell Non-Hodgkin Lymphoma (B-NHL), B-cell Acute Lymphoblastic Leukemia (B-ALL)

In brief

This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

Key facts

Study ID

NCT05397496

Run by

Novartis Pharmaceuticals

People needed

61

Starts

2022-10-03

Expected to finish

2027-01-04

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent must be obtained prior to participation in the study.
• Male or female patients ≥18 years of age at the date of signing the informed consent form
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• NHL patient population
• Refractory or relapsed B-NHL
• Must have relapsed after or failed to respond to at least two prior treatment therapies including an αCD20 monoclonal antibody containing chemotherapy combination regimen
• Must have at least one bi-dimensionally measurable nodal lesion or one bi-dimensionally measurable extranodal lesion, as measured on positron emission tomography-computed tomography (PET/CT) scan
• ALL patient population
• Refractory or relapsed CD19-positive B-ALL
• Morphologic disease in the bone marrow (≥ 5% blasts)

You may not qualify if…

• History of severe hypersensitivity to any ingredient of the study treatment or its excipients
• Contraindication to tocilizumab
• History of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection
• Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type
• Active central nervous system (CNS) involvement by malignancy or presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within the 2 weeks prior to the start of study treatment
• Active, known or suspected autoimmune disease other than patients with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur
• Patients receiving systemic treatment with any immunosuppressive medication
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• University Of Miami — Miami, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• The University of Kansas Clinical Research Ctr — Fairway, Kansas, United States
• Memorial Sloan Kettering Cancer Ctr — New York, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Beijing, China
• Novartis Investigative Site — Shanghai, China
• Novartis Investigative Site — Tianjin, China
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Tel Aviv, Israel
• Novartis Investigative Site — Reggio Emilia, RE, Italy
• Novartis Investigative Site — Kashiwa, Chiba, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Barcelona, Spain

Full record on ClinicalTrials.gov

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